Tap any paragraph to write a margin note. Your notes collect in the Desk below the text and file under cases with @. The side-by-side margin rail opens on a larger screen.

§
Marginalia
Code · REGISTER · 2007-10-04 · Public Buildings Service, GSA · Notices

Notices. Notice of Availability and Public Hearing

11,987 words·~54 min read·/register/2007/10/04/07-4932

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 6760-01-M GENERAL SERVICES ADMINISTRATION Notice of Availability of the Draft Environmental Assessment for Improvements to the Nogales Mariposa U.S. Port of Entry, Nogales, Arizona AGENCY: Public Buildings Service, GSA ACTION: Notice of Availability and Public Hearing. SUMMARY: The General Services Administration
(GSA)announces the availability of the Draft Environmental Assessment
(EA)for Improvements to the Nogales Mariposa U.S. Port of Entry, Nogales, Arizona, for public review and comment. The EA provides GSA and its stakeholders an analysis of the environmental impacts resulting from ongoing operations as well as reasonable alternatives for new operations and facilities at the Nogales Mariposa U.S. Port of Entry, located in southern Arizona. DATES: Written comments on the Draft EA are invited from the public and may be submitted during the comment period, which begins today and ends November 30, 2007 (see ADDRESSES section for more details). Comments must be postmarked by November 30, 2007, to ensure consideration. The GSA will use the comments received to help prepare the final version of the Nogales Mariposa U.S. Port of Entry EA. A public meeting on the Draft EA will be held on Tuesday, October 16, 2007, from 4 p.m. to 8 p.m. at the Santa Cruz County Office Building, 2150 North Congress Drive, Nogales, Arizona. The hearing will provide opportunities for information exchange and discussion between GSA and the public, as well as for submitting prepared statements. For more information call (619)557-6169. ADDRESSES: Comments may be submitted in writing to: Greg Smith, NEPA Project Manager, GSA, 880 Front St., Room 4236, San Diego, CA 92101, or via e-mail to *greg.smith@gsa.gov* . Oral and written comments may also be submitted at the public hearing described in the DATES section. Copies of the Draft Nogales Mariposa U.S. Port of Entry EA may be downloaded from *http:\\www.gsa.gov/nepalibrary* . Other matters regarding this environmental review should be referred to Greg Smith at the address above. SUPPLEMENTARY INFORMATION: A notice of availability will be mailed to all agencies, organizations, and individuals who participated in the scoping process or were identified during the EA process. GSA has distributed copies of the Draft Nogales Mariposa U.S. Port of Entry EA to appropriate agencies of, the state of Arizona, local county governments, other federal agencies, and other interested parties who have already requested copies. After the public comment period, which ends November 30, 2007, GSA will consider the comments received, revise the Draft EA if necessary, and issue a Final EA. GSA will consider the Final EA, along with other economic and technical considerations, to make a decision on the appropriate course for improvements to the Nogales Mariposa U.S. Port of Entry. Dated: September 28, 2007. Peter G. Stamison, Regional Administrator,Pacific Rim Region. [FR Doc. E7-19662 Filed 10-3-07; 8:45 am] BILLING CODE 6820-YF-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-07-06BP] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)639-5960 or send an e-mail to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Outcomes Data Collection of the National Prevention Information Network—New—National Center for HIV, Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The National Center for HIV, Hepatitis, STD, and TB Prevention (NCHHSTP) within the Centers for Disease Control and Prevention
(CDC)proposes a survey data collection to assess the CDC National Prevention Information Network's
(NPIN)Web site, products and services. The CDC NPIN serves as the U.S. reference, referral, and distribution service for information on HIV/AIDS, STDs, TB and viral Hepatitis. Products and services offered by the CDC NPIN Web site is the primary channel used by the CDC to provide information concerning prevention, treatment, and care of HIV, STD, TB, and viral Hepatitis to its prevention partners, stakeholders, and other constituents. The CDC NPIN Web site includes several searchable databases that can be used to locate information about testing centers, funding opportunities, upcoming conferences, educational materials, and news. The Web site is a widely used service by the public, with more than 54 million hits and 3 million visits recorded since August 2004. Following enhancements to the website completed in February 2006, 22,886,855 hits and 1,349,318 visits have already been recorded from February to November 2006. In addition to the Web site, consumers can access information and order materials and resources by phone using the NPIN toll-free reference and referral line or electronic mail system. As of January 25, 2007, over 370,000 unique requests for materials have been logged and 4,561,186 materials have been ordered by the public. The primary purposes of the proposed data collection are to assess CDC NPIN users' satisfaction and perceived quality with the Web site, products, and services; determine the extent to which the users' needs are being met; and identify how the Web site, products, and services can be enhanced to meet the needs of the user. The evaluation will be accomplished by survey data collection from users of the CDC NPIN Web site and users of CDC NPIN products and services. Organizations that do not have access to the Internet will be administered the survey by phone. The estimated 5,655 respondents include representatives from government agencies, community-based organizations, advocacy organizations, and various other organizations involved in the prevention and/or treatment of HIV/AIDS, STDs, TB, and/or viral Hepatitis. There are no costs to respondents other than their time. The total estimated annual burden hours are 2,525. Estimated Annualized Burden Hours Form Type of respondent Number of respondents Number of responses per respondent Average burden per response NPIN Website User Survey All NPIN Users (Individuals) 1,078 1 13/60 NPIN Products and Services User Survey Private Sector Organizations State and local government organization 2,155 222 2 2 15/60 15/60 Federal government organization 94 2 15/60 Individual/Households 1,648 2 15/60 NPIN Products and Services User Survey (Telephone) Private Sector Organizations State and local government organization 239 25 2 2 15/60 15/60 Federal government organization 11 2 15/60 Individual/Households 183 2 15/60 Dated: September 27, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-19620 Filed 10-3-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number NIOSH-110] Notice of Public Meeting and Availability for Public Comment AGENCY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of Public Meeting and Availability for Public Comment. SUMMARY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention
(CDC)announces a public meeting and request for public input regarding a proposed survey of U.S. truck driver safety and health. The goal of the survey is to collect information on truck driver health, sleep disorders, fatigue, working conditions, and non-fatal injuries. Further information on the proposed survey may be found at: *http://www.cdc.gov/niosh/review/public/110.* *Public Comment Period:* From date of publication of this notice until January 2, 2008. *Public Meeting Date and Time:* Thursday, November 1, 2007, 8:30 a.m.-4:30 p.m., CST. *Place:* Westin O'Hare Hotel, 6100 North River Road, Rosemont, Illinois 60018, telephone
(888)627-8517. *Purpose of the Meeting:* To obtain public comment on the content and conduct of a nationally representative survey of truck drivers' safety and health. Special emphasis will be placed on discussion of the following:
(1)Content of the survey.
(2)Appropriate methods of conducting such a survey. *Status:* The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public. Attendance is limited only by the space available. The meeting room will accommodate approximately 70 people. Interested parties should make hotel reservations directly with the Westin O'Hare Hotel by calling
(888)627-8517 or via the Web site at *http://www.starwoodmeeting.com/Book/westatOc* before the cut-off date of 5 p.m. CST October 10, 2007. A special group rate of $205.00 per night (or prevailing government rate) plus tax per night for meeting guests has been negotiated for this meeting. In order to receive the special room rate, you will need to indicate that you will be attending the NIOSH meeting. Interested parties should confirm their attendance to this meeting by contacting Ms. Mary K. Dingwall, meeting coordinator, at
(301)738-3583 or *MaryDingwall@Westat.com* by October 19, 2007. Oral comments given at the meeting will be recorded and included in the docket. Written comments will also be accepted at the meeting or by submitting them to the NIOSH Docket Office. *Contact Person for Technical Information:* Karl Sieber, NIOSH/CDC, Robert A. Taft Laboratories, 4676 Columbia Pkwy. MS R-17, Cincinnati, OH 45226, telephone
(513)841-4231, or Stephanie Pratt, NIOSH/CDC, 1095 Willowdale Road, MS 1808, Morgantown, WV 26505, telephone
(304)285-5992. *Contact Person for Submitting Comments:* Comments on the topics presented in this notice and at the meeting should be mailed to: NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone
(513)533-8450, fax
(513)533-8285. Comments may also be submitted by e-mail to *nioshdocket@cdc.gov* or at *http://www.cdc.gov/niosh/review/public/110/.* E-mail attachments should be formatted in Microsoft Word. All comments should be received by January 2, 2008 and should reference the Docket Number (NIOSH-110) in the subject heading. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226 and at *http://www.cdc.gov/niosh/docket/default.html.* Dated: September 26, 2007. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E7-19613 Filed 10-3-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Proposed Consolidated Vaccine Information Materials for Multiple Infant Vaccines AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. SUMMARY: Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on a proposed new vaccine information statement that consolidates the six vaccine information statements for the following childhood vaccines: DTaP, *Haemophilus influenzae* type b, inactivated polio vaccine, pneumococcal conjugate vaccine, hepatitis B, and rotavirus. This consolidated Vaccine Information Statement would be available to be used by vaccination providers as an alternative to providing the six individual Vaccine Information Statements for the same vaccines. DATES: Written comments are invited and must be received on or before December 3, 2007. ADDRESSES: Written comments should be addressed to Anne Schuchat, M.D., Director, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Mailstop E-05, 1600 Clifton Road, N.E., Atlanta, Georgia 30333. FOR FURTHER INFORMATION CONTACT: Anne Schuchat, M.D., Director, National Center for Immunization and Respiratory Diseases, Mailstop E-05, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone
(404)639-8200. SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of 1986 (Pub. L. 99-660), as amended by section 708 of Public Law 103-183, added section 2126 to the Public Health Service Act. Section 2126, codified at 42 U.S.C. 300aa-26, requires the Secretary of Health and Human Services to develop and disseminate vaccine information materials for distribution by all health care providers in the United States to any patient (or to the parent or legal representative in the case of a child) receiving vaccines covered under the National Vaccine Injury Compensation Program. Development and revision of the vaccine information materials, also known as Vaccine Information Statements (VIS), have been delegated by the Secretary to the Centers for Disease Control and Prevention (CDC). Section 2126 requires that the materials be developed, or revised, after notice to the public, with a 60-day comment period, and in consultation with the Advisory Commission on Childhood Vaccines, appropriate health care provider and parent organizations, and the Food and Drug Administration. The law also requires that the information contained in the materials be based on available data and information, be presented in understandable terms, and include:
(1)A concise description of the benefits of the vaccine,
(2)A concise description of the risks associated with the vaccine,
(3)A statement of the availability of the National Vaccine Injury Compensation Program, and
(4)Such other relevant information as may be determined by the Secretary. The vaccines initially covered under the National Vaccine Injury Compensation Program were diphtheria, tetanus, pertussis, measles, mumps, rubella and poliomyelitis vaccines. Since April 15, 1992, any health care provider in the United States who intends to administer one of these covered vaccines is required to provide copies of the relevant vaccine information materials prior to administration of any of these vaccines. Hepatitis B, *Haemophilus influenzae* type b (Hib), varicella (chickenpox), pneumococcal conjugate, hepatitis A, meningococcal conjugate and polysaccharide, rotavirus, human papillomavirus (HPV), and trivalent influenza vaccines have subsequently been added to the National Vaccine Injury Compensation Program. Use of the Vaccine Information Statements applicable to all of these vaccines, except meningococcal, rotavirus and HPV, is also required. (Interim versions of Vaccine Information Statements for meningococcal, rotavirus and HPV vaccines are available for discretionary use pending completion of the statutory process for finalizing VISs applicable to those vaccines.) Instructions for use of the vaccine information materials and copies of the materials can be found on the CDC Web site at: *http://www.cdc.gov/vaccines/pubs/vis.* In addition, single camera-ready copies are available from State health departments. A list of State health department contacts for obtaining copies of these materials is included in a December 17, 1999 **Federal Register** notice (64 FR 70914). Proposed Consolidated Vaccine Information Materials With six vaccines recommended for infants from birth through 6 months of age—all covered by the National Vaccine Injury Compensation Program—CDC, as required under 42 U.S.C. 300aa-26, developed Vaccine Information Statements for each of those vaccines. CDC is proposing an alternative consolidated Vaccine Information Statement covering those six vaccines in one document, which providers could choose to use instead of the existing individual Vaccine Information Statements for the same vaccines. Development of Vaccine Information Materials The vaccine information materials referenced in this notice are being developed in consultation with the Advisory Commission on Childhood Vaccines, the Food and Drug Administration, and parent and health care provider groups. In addition, we invite written comment on the proposed vaccine information materials that follow, entitled “Your Baby's First Vaccines: What You Need to Know.” Comments submitted will be considered in finalizing these materials. When the final consolidated VIS is published in the **Federal Register** , the instructions for use of vaccine information materials will be revised to note that this alternative consolidated VIS can be used in lieu of the individual vaccine VISs. Proposed Multi-vaccine Vaccine Information Statement YOUR BABY'S FIRST VACCINES: WHAT YOU NEED TO KNOW Babies are scheduled for six vaccines at 2, 4, and 6 months of age. One of these (hepatitis B) is usually given at birth. These vaccines protect your baby from 8 serious diseases (see the next page). Your baby will be getting these vaccines today (check): ○ DTaP ○ Hib ○ Polio ○ Pneumococcal ○ Hepatitis B ○ Rotavirus Some of these vaccines might be given in the same shot (for example, Hepatitis B and Hib, or DTaP, Polio and Hepatitis B). These “combination vaccines” are as safe and effective as the individual vaccines, and mean fewer shots for your baby. These vaccines may all be given at the same visit. Getting several shots at the same time does not increase the risk to your baby. This “Vaccine Information Statement” tells you about the benefits and risks of these 6 vaccines. It also contains information about reporting an adverse reaction, the National Vaccine Injury Compensation Program, and how to get more information about childhood diseases and vaccines. Please read this statement before your child gets his or her immunizations, and take it home with you afterward. Ask your doctor, nurse, or other healthcare provider if you have questions. Department of Health and Human Services, Centers for Disease Control and Prevention, Vaccine Information Statement, 42 U.S.C. 300aa-26, X/X/2007. Vaccine Benefits: Why get vaccinated? Your baby's first vaccines protect them from 8 serious diseases, caused by viruses and bacteria. These diseases have injured and killed many children (and adults) over the years. Polio paralyzed about 37,000 people and killed about 1,700 each year in the 1950s before there was a vaccine. In the 1980s, Hib disease was the leading cause of bacterial meningitis in children under 5 years of age. About 15,000 people a year died from diphtheria before there was a vaccine. Most children have had at least one rotavirus infection by their 5th birthday. Most of these diseases are not very common in the U.S. today. But if we stopped vaccinating, they would come back. This has happened in other parts of the world. 8 Serious Diseases Diphtheria Bacteria You can get it from contact with an infected person, mainly through the air. Signs and symptoms include a thick covering in the back of the throat. It can lead to breathing problems, heart failure, and death. Tetanus (Lockjaw) Bacteria You can get it from a cut or wound. It does not spread from person to person. Signs and symptoms include painful tightening of the muscles, usually all over the body. It can lead to stiffness of the jaw, so the victim cannot open his mouth or swallow. It leads to death in about 1 case out of 10. Pertussis (Whooping Cough) Bacteria You can get it from contact with an infected person, mainly through the air. Signs and symptoms include violent coughing spells that can make it hard for an infant to eat, drink, or breathe. These spells can last for weeks. It can lead to pneumonia, seizures (jerking and staring spells), brain damage, and death. Hib ( *Haemophilus influenzae* type b) Bacteria You can get it from contact with an infected person, mainly through the air. Signs and symptoms. There may be no signs or symptoms in mild cases. It can lead to meningitis (infection of the brain and spinal cord coverings); pneumonia; infections of the blood, joints, bones, and covering of the heart; brain damage; deafness; and death. Hepatitis B Virus You can get it from contact with blood or body fluids of an infected person. Babies can get it at birth if the mother is infected, or through a cut or wound. Adults can get it from unprotected sex, sharing needles, or other exposures to blood. Signs and symptoms include tiredness, diarrhea and vomiting, jaundice (yellow skin or eyes), and pain in muscles, joints and stomach. It can lead to liver damage, liver cancer, and death. Polio Virus You can get it from close contact with an infected person. It enters the body through the mouth. Signs and symptoms can include a cold-like illness, or there may be no signs or symptoms at all. It can lead to paralysis (can't move arm or leg), or death (by paralyzing breathing muscles). Pneumococcal Bacteria You can get it from contact with an infected person, mainly through the air. Signs and symptoms include fever, chills, cough, and chest pain. It can lead to meningitis (infection of the brain and spinal cord coverings), blood infections; ear infections, pneumonia, deafness, brain damage, and death. Rotavirus Virus You can get it from contact with other children who are infected. Signs and symptoms include severe diarrhea, vomiting and fever. It can lead to dehydration, hospitalization (up to about 70,000 children a year), and death. How Vaccines Work A child who gets sick with one of these diseases becomes immune to that disease, and won't get it again. But getting the disease the first time can be dangerous. That's why vaccines are a better way to create immunity. Vaccines are made with the same bacteria or viruses that cause the disease, but they have been weakened or killed to make them safe. Vaccines fool the immune system into thinking a child has the disease. The child becomes immune without having to get sick first. Routine Childhood Vaccines These 6 vaccines are routinely given to children under 6 months of age. Children will also get at least one “booster” dose of most of these vaccines when they are older. • DTaP (Diphtheria, Tetanus & Pertussis) Vaccine: 5 doses—2 months, 4 months, 6 months, 15-18 months, 4-6 years. Some children should not get pertussis vaccine. These children can get a vaccine called DT, which does not contain pertussis vaccine. • Hepatitis B vaccine: 3 doses—Birth, 1-2 months, 6-18 months. • Polio Vaccine: 4 doses—2 months, 4 months, 6-18 months, 4-6 years. • Hib ( *Haemophilus influenzae* type b) Vaccine: 4 doses—2 months, 4 months, 6 months, 12-15 months. Several Hib vaccines are available. With one type, the 6-month dose is not needed. • Pneumococcal Vaccine: 4 doses—2 months, 4 months, 6 months, 12-15 months. Older children with certain chronic diseases may also need this vaccine. • Rotavirus Vaccine: 3 doses—2 months, 4 months, 6 months. Rotavirus is an oral (swallowed) vaccine, not a shot. Vaccine Risks Like any medicine, vaccines can cause side effects. Most of these are mild “local reactions” such as tenderness, redness or swelling where the shot is given, or a mild fever. These reactions are part of the body's natural immune response. They can occur in up to 1 child out of 4 for most childhood vaccines. They appear soon after the shot is given and go away within a day or two. These do not occur with rotavirus vaccine, since it is not injected. More severe side effects can occur, but much less often. Some of them occur so rarely that experts can't tell whether they are caused by vaccines or not. Among the most serious reactions to vaccines are severe allergic reactions to a substance in a vaccine. These reactions are very rare—less than one in a million shots. Usually they occur very soon after the shot is given. Doctor's office or clinic staff are trained to deal with them. The risk of any vaccine causing serious harm, or death, is extremely small. Getting a disease is much more likely to cause harm than getting a vaccine. The following conditions (in addition to local reactions and mild fever) have been associated with routine childhood vaccines. By “associated” we mean that they are reported after vaccinations more often than would be expected to occur by chance. This does not “prove” that the vaccine causes the reaction, but suggests that it is likely. DTaP Vaccine *Mild Problems:* Fussiness (up to 1 child in 3); Tiredness or Poor Appetite (up to 1 child in 10); Vomiting (up to 1 child in 50); Swelling of the entire arm or leg for 1-7 days (up to 1 child in 30)—usually after the 4th or 5th dose. *Moderate Problems:* Seizure (jerking or staring) (1 child in 14,000); Non-stop crying for 3 hours or more (up to 1 child in 1,000); Fever over 105°F (1 child in 16,000). *Serious Problems:* Long-term seizures, coma, lowered consciousness, and permanent brain damage have been reported very rarely after DTaP vaccine. They are so rare it is not possible to tell if they are caused by the vaccine. Polio Vaccine/Hepatitis B Vaccine/Hib Vaccine These vaccines have not been associated with moderate or serious problems. Pneumococcal Vaccine Mild Problems: During studies of the vaccine, some children became fussy or drowsy or lost their appetite. Rotavirus Vaccine Mild Problems: Children are slightly (1-3%) more likely to have mild, temporary diarrhea or vomiting within a week after getting a dose of rotavirus vaccine than children who have not gotten the vaccine. No moderate or severe problems have been associated with the vaccine. Check With Your Doctor * * * Most children can get all childhood vaccines, but some children should not. Sometimes a child should wait until after the recommended age before getting vaccinated. If your child is sick on the date vaccinations are scheduled, ask your doctor about delaying them. A child with a mild cold or other illness, or a low fever, can usually be vaccinated. But with more serious illnesses, the doctor might want to wait until the child recovers. The doctor might recommend that some children not get a specific vaccine. This includes any child who had a life-threatening reaction to a previous dose of the vaccine, or has a life-threatening allergy to any vaccine component. Other reasons not to get a specific vaccine include if the child has/had: DTaP Vaccine —A brain or nervous system disease within 7 days after a previous dose of DTaP. —A seizure or collapse after a previous dose of DTaP. —Non-stop crying for 3 hours or more after a previous dose of DTaP. —A fever over 105°F after a previous dose of DTaP. Polio Vaccine —A life-threatening allergy to the antibiotics neomycin, streptomycin, or polymyxin B. Hepatitis B Vaccine —A life-threatening allergy to baker's yeast (the kind used for making bread). Rotavirus Vaccine —A child who has had intussusception (an uncommon type of bowel obstruction) should usually not be given rotavirus vaccine. (This is simply a precaution. An older type of rotavirus vaccine, which is no longer used, was associated with several cases of intussusception. Today's vaccine has not been. But children who have had this condition are at increased risk of getting it again.) What if there is a moderate or severe reaction? What should I look for? Look for any unusual condition, such as a serious allergic reaction, high fever, or unusual behavior. Serious allergic reactions are extremely rare with any vaccine. If one were to happen, it would most likely come within a few minutes to a few hours after the shot. *Signs of a serious allergic reaction can include:* —difficulty breathing —weakness —hives —hoarseness or wheezing —dizziness —paleness —swelling of the throat —fast heart beat What should I do? Call a doctor, or get the child to a doctor right away. Tell your doctor what happened, the date and time it happened, and when the shot was given. Ask your doctor, nurse, or health department to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS website at *http://www.vaers.org* , or by calling 1-800-822-7967. *VAERS does not provide medical advice. * The National Vaccine Injury Compensation Program In the unlikely event that your child has a serious reaction to a vaccine, a federal program exists to help pay for the care of those who have been harmed. For information about the National Vaccine Injury Compensation Program, call 1-800-338-2382 or visit their website at *http://www.hrsa.gov/vaccinecompensation* . For More Information Ask your doctor or nurse. They can give you the vaccine package insert or suggest other sources of information. Call your local or state health department. Contact the Centers for Disease Control and Prevention
(CDC)at 1-800-232-4636 (1-800-CDC-INFO). Visit CDC Web sites at: *http://www.cdc.gov/vaccines* and *http://www.cdc.gov/ncidod/diseases/hepatitis* . Dated: September 26, 2007. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention (CDC). [FR Doc. E7-19615 Filed 10-3-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Fees for Sanitation Inspections of Cruise Ships AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY: This notice announces fees for vessel sanitation inspections for fiscal year 2008 (October 1, 2007, through September 30, 2008). DATES: *Effective Date:* October 1, 2007. FOR FURTHER INFORMATION CONTACT: Jaret Ames, Chief, Vessel Sanitation Program, National Center for Environmental Health, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, NE., Mailstop F-23, Atlanta, Georgia 30341-3724, telephone
(770)488-3139, E-mail: *Dforney@cdc.gov.* SUPPLEMENTARY INFORMATION: Purpose and Background The fee schedule for sanitation inspections of passenger cruise ships inspected under the Vessel Sanitation Program
(VSP)was first published in the **Federal Register** on November 24, 1987 (52 FR 45019), and CDC began collecting fees on March 1, 1988. Since then, CDC has published the fee schedule annually. This notice announces fees effective October 1, 2007. The formula used to determine the fees is as follows: EN04oc07.008 The average cost per inspection is multiplied by a size/cost factor to determine the fee for vessels in each size category. The size/cost factor was established in the proposed fee schedule published in the **Federal Register** on July 17, 1987 (52 FR 27060), and revised twice and published in the **Federal Register** on November 28, 1989 (54 FR 48942) and November 21, 2005 (70 FR 70078). The revised size/cost factor is presented in Appendix A. Fee The fee schedule (Appendix A) will be effective October 1, 2007, through September 30, 2008. If travel expenses continue to increase, the fees may need adjustment before September 30, 2008, because travel constitutes a sizable portion of VSP's costs. If an adjustment is necessary, a notice will be published in the **Federal Register** 30 days before the effective date. Applicability The fees will apply to all passenger cruise vessels for which inspections are conducted as part of CDC's VSP. Dated: September 26, 2007. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention (CDC). Appendix A Vessel Size GRT 1 Approximate cost ($US) per GRT SIZE/COST FACTOR Extra Small < 3,001 0.25 Small 3,001-15,000 0.50 Medium 15,001-30,000 1.00 Large 30,001-60,000 1.50 Extra Large 60,001-120,000 2.00 Mega * > 120,001 3.00 Vessel Size GRT 1 Fee ($US) FEE SCHEDULE Extra Small < 3,000 1,300 Small 3,001-15,000 2,600 Medium 15,001-30,000 5,200 Large 30,001-60,000 7,800 Extra Large 60,001-120,000 10,400 Mega * >120,001 15,600 1 Gross register tonnage in cubic feet, as shown in Lloyd's Register of Shipping. * New Vessel Size Category. Inspections and reinspections involve the same procedure, require the same amount of time, and are therefore charged at the same rate. [FR Doc. E7-19609 Filed 10-3-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007F-0355] Dean Foods Co.; Filing of Food Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that Dean Foods Co. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of vitamin D <sup>2</sup> as a nutrient supplement in soy-based food products. FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1071. SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 7A4769) has been filed by Dean Foods Co., c/o Hogan and Hartson LLP, 555 13th St., NW., Washington, DC 20004-1109. The petition proposes to amend the food additive regulations in part 172 *Food Additives Permitted for Direct Addition to Food for Human Consumption* (21 CFR part 172) to provide for the safe use of vitamin D <sup>2</sup> as a nutrient supplement in soy-based food products. The agency has determined under 21 CFR 25.32(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. Dated: September 26, 2007. Laura M. Tarantino, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. E7-19576 Filed 10-3-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0356] Behind the Counter Availability of Certain Drugs; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and Drug Administration
(FDA)is announcing a public meeting to obtain comments regarding behind-the-counter
(BTC)availability of drugs. Currently, drugs are available as prescription and non-prescription. Generally, non-prescription products are available in an “over-the-counter”
(OTC)manner. The FDA is interested in obtaining public comment as it explores the public health benefit of certain drugs being available without a prescription but only after intervention by a pharmacist. The purpose of the meeting is to solicit information and views from interested persons on specific issues associated with BTC availability, including the impact on patient access to safe and effective drug products. *Dates and Times* : The public meeting will be held on November 14, 2007, from 8 a.m. to 5 p.m. *Location* : The public meeting will be held at the National Transportation Safety Board Conference Center, 429 L'Enfant Plaza SW., Washington, DC 20594. ADDRESSES: Submit written registration and written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic registration to *http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm* . Submit electronic comments to *http://www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm* . Transcripts of the meeting will be available for review at the Division of Dockets Management and on the Internet at *http://www.fda.gov/ohrms/dockets* approximately 30 days after the meeting. *For Registration to Attend and/or Participate in the Meeting* : Seating at the meeting is limited. People interested in attending should submit written or electronic registration to the Division of Docket Management (see ADDRESSES ) by close of business on November 5, 2007. Registration is free and will be on a first-come, first-serve basis. Written or electronic comments will be accepted until November 28, 2007. If you wish to make an oral presentation at the meeting, you must state your intention on your registration submission (see ADDRESSES ). To speak, submit your name, title, business affiliation, address, telephone number, fax number, and e-mail address. FDA has included questions for comment in this notice. You should also identify by number each question you wish to address in your presentation. FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and to request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. If you need special accommodations due to a disability, please inform Erik Mettler (see *For Information on the Meeting Contact* ). *For Information on the Meeting Contact* : Erik Mettler, Office of Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, rm. 14-101, Rockville, MD 20857, 301-827-3360, FAX: 301-594-6777, e-mail: *Erik.Mettler@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background FDA is committed to ensuring the safety and efficacy of all drug products it regulates. FDA is exploring the public health benefit of certain drugs being available BTC that were previously prescription medications. BTC could be comprised of certain medications available behind the counter at the pharmacy without a prescription and require the intervention of a pharmacist before dispensing. Some groups have asserted that pharmacist interaction with the consumer could ensure safe and effective use of a drug product that otherwise might require a prescription. Because pharmacists have the training and knowledge to provide certain interventions, they may be able to ensure that patients meet the conditions for use and educate patients on appropriate use of the drug product. These groups have suggested, moreover, that the availability of certain drugs BTC could increase patient access to medications that may be underutilized, particularly by patients without health insurance because these medications otherwise would be available only with a prescription. Variations of a BTC status are already in effect in other countries, including Australia, Canada, France, New Zealand, United Kingdom (UK), Denmark, Germany, Italy, Netherlands, Sweden, and Switzerland. In the UK, there is a “pharmacist-only” class of drugs, while the other countries have more than three classes. In general, foreign countries have used the following criteria for switching a drug from prescription to intermediate class:
(1)Indications suitable for self-medication, including self-diagnosis, with the intervention of a pharmacist and
(2)the medicine has a low potential for side effects or overdose, and intervention by a pharmacist could minimize these risks. Other considerations include: Abuse potential, patient choice and accessibility, and public health issues. With the pharmacy-only classification, typically the pharmacist is required to ensure the patient meets certain criteria prior to dispensing, as well as to provide education on proper use and monitoring. Accordingly, FDA is interested in exploring the public health implications of BTC dispensing of certain drug products, including (among other things) the implications for patient access and utilization, including drug prices, the continued safety and effectiveness of drugs, and patient compliance with drug therapy. II. Scope of Meeting FDA is interested in obtaining public comment on BTC availability of certain drugs, the appropriate regulatory framework for such drugs, and criteria for BTC availability. Specifically, we are seeking input on the following issues related to BTC: *General* 1. Should there be BTC availability of certain drug products? If so why? If not why? 2. What might the impact of BTC be on patient access? 3. What might the impact of BTC be on patient compliance with drug therapy? 4. What should the criteria or standards be for a drug to be treated as BTC? 5. Please comment on the following criteria for what roles a pharmacist or other health professional might play, which are included below for discussion purposes. For example, a pharmacist or other practitioner licensed by law to dispense prescription drugs prior to sale might:
(A)Review or conduct an initial screening for clinical laboratory test results, contraindications, or drug interactions;
(B)Counsel the patient on safe use;
(C)Monitor for continued safe or effective use. 6. Should BTC availability be used as a temporary or transitional status for drugs that move from prescription status to OTC versus a permanent status? 7. Should there be criteria or standards for a drug to transition out of BTC status to OTC status? If so, what should these criteria or standards be? 8. If safety concerns arise, should there be criteria or standards for a drug to transition out of BTC status to prescription status? Or from OTC status to BTC status? If so what should these criteria or standards be for each scenario? 9. What effect would BTC availability have on patient access to medications in this category? 10. How could we evaluate whether BTC improves patient access to medications? 11. Would BTC availability be cost-effective to patients? Please explain. 12. What effect would BTC availability have on patient safety? 13. What measures would be necessary to ensure patient safety? 14. In general, what are the benefits and costs to the healthcare system as a whole related to BTC availability? *Logistics* 1. Discuss logistical challenges for pharmacy storage and dispensing of BTC drugs. How might these challenges be addressed? 2. What dispensing procedures should be associated with BTC medications? 3. What types of records should be kept in association with BTC dispensing? If such records were to include patient laboratory values, how would the pharmacist gain access to this information as well as other information in the patient's medical records? 4. How would patient privacy be protected in a retail pharmacy setting? Please discuss any privacy concerns that would need to be addressed. 5. Should reimbursement be available to pharmacists for providing services associated with BTC dispensing? What type? What type of billing procedures could be utilized and how would third party companies facilitate such reimbursements? 6. Who would oversee a BTC program? What impact would it have on States and what might be the role for the State boards of pharmacy? 7. Would special training be needed for pharmacists to participate in dispensing BTC medications? If any, what type of training would this entail? 8. Would special training be needed for other pharmacy staff to aid in managing the work flow (storage, record keeping, distribution) and additional BTC responsibilities of the pharmacist(s) and the pharmacy? If so, what type of training or measures should be put in place? 9. Could qualified healthcare professionals/providers other than pharmacists be responsible for dispensing of BTC drugs? If so, what types of healthcare professionals/providers? And in what type of settings could this situation be accommodated? 10. What impact would BTC availability of drugs have on the practice of pharmacy? 11. What impact would BTC availability of drugs have on the practice of medicine? III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic notices of participation and comments for consideration. To permit time for all interested persons to submit data, information, or views on this subject, the docket for the meeting will open 14 days prior to the meeting and remain open for 30 days following the meeting. Persons who wish to provide additional materials for consideration should file these materials with the Division of Dockets Management. You should annotate and organize your comments to identify the specific questions identified by the number and subject to which they refer in the previous text in this document. Please identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Transcripts of the meeting also will be available for review at the Division of Dockets Management. Dated: September 25, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-19329 Filed 10-3-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. [2001D-0193 (formerly 01D-0193)] Guidance for Industry and Food and Drug Administration Staff; Biological Indicator Premarket Notification Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of the guidance entitled “Biological Indicator
(BI)Premarket Notification (510(k)) Submissions.” The agency is issuing this guidance document to provide information that will help manufacturers prepare premarket notification submissions for these devices. The document provides guidance regarding performance characteristics for biological indicator devices, which are intended to monitor the effectiveness of sterilizers used in healthcare facilities. DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled “Biological Indicator
(BI)Premarket Notification (510(k)) Submissions” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151 or 1-800-638-2041. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to either *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Sheila Murphey, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3747. SUPPLEMENTARY INFORMATION: I. Background This guidance is for biological indicator devices intended for use in health care facilities to monitor the effectiveness of sterilizers. Biological sterilization process indicators are class II devices identified in 21 CFR 880.2800(a). In the **Federal Register** of May 21, 2001 (66 FR 27985), FDA invited interested persons to comment on the draft guidance entitled “Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers.” FDA received five comments on the draft guidance. Many of the comments are addressed by the voluntary consensus standards that have been recognized by FDA since the draft was issued and that are now cited in the guidance. We addressed comments that suggested the statistics in the validation protocol were too restrictive by clarifying that these statistics are examples, not thresholds. We also revised the guidance for clarity and brevity in response to the comments received. II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on “biological indicator premarket notification submissions.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive “Biological Indicator
(BI)Premarket Notification (510(k)) Submissions” you may either send an e-mail request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1320 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is available at *http://www.fda.gov/cdrh/guidance.html* . Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (44 USC 3501-3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB Control Number 0910-0120. The labeling provisions addressed in the guidance have been approved under OMB Control Number 0910-0485. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: September 26, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-19573 Filed 10-3-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0309] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of the draft guidance entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” The draft guidance describes a means by which the electrocardiograph electrode device may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the **Federal Register** , FDA is publishing a proposed rule that would designate this draft guidance as the special control for this device and would exempt the device from premarket notification requirements, subject to specific limitations, if the device addresses the issues identified in the guidance by following its recommendations. The draft guidance document is not final, nor is it being implemented at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 2, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to either *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Sharon Lappalainen, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4095, or by e-mail at *Sharon.Lappalainen@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of February 5, 1980 (45 FR 7926), FDA issued a final rule classifying the electrocardiograph electrode into class II, under the Federal Food, Drug, and Cosmetic Act (the act). An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. FDA has now developed a draft guidance document for the device and, under the act's provisions, is proposing to designate the draft guidance as the special control that, when combined with the general controls, the agency believes will provide a reasonable assurance of the safety and effectiveness of this device type. Elsewhere in this issue of the **Federal Register** , FDA is publishing a proposed rule that would designate this draft guidance document as the special control for this device and would exempt the device from premarket notification requirements, subject to limitations in 21 CFR 870.9, if the device addresses the issues identified in the special controls guidance by following the draft guidance's recommendations. The draft special controls guidance document identifies the classification, product code, and classification identification for the electrocardiograph electrode device. In addition, the draft guidance document identifies the risks to health and serves as a special control that, when followed and combined with the general controls, will generally address the risks associated with this generic device type and permit introduction of the device to the market. II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on the device. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive “Class II Special Controls Guidance Document: Electrocardiograph Electrodes” you may either send an e-mail request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number
(1597)to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is available at *http://www.fda.gov/cdrh/guidance.html* . Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ), written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: September 26, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-19578 Filed 10-3-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0348] Establishing a Docket for the Development of Safety and Effectiveness Assessments of Vaccines Used for Pandemic Influenza; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the opening of a docket to receive information and comments from manufacturers of vaccines and other interested persons concerning the development of safety and effectiveness assessments of vaccines used for pandemic influenza. FDA is interested in obtaining comments and information to aid in the development of programs for adverse events surveillance following administration of pandemic influenza vaccines, and in the development of protocols to study effectiveness of influenza vaccines in pre-pandemic and pandemic situations. DATES: Submit written or electronic comments on the safety and effectiveness assessments of vaccines for pandemic influenza use, and comments on information submitted to the docket by other interested persons by December 3, 2007. ADDRESSES: Submit written comments and information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852-1448. Submit electronic comments or information to either *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr. Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: I. Background The National Strategy for Pandemic Influenza was issued by President Bush in November 2005. This National Strategy identifies the U.S. Department of Health and Human Services
(HHS)as the lead for medical response and is intended to guide our nation's preparedness and response to pandemic influenza. The Implementation Plan for the National Strategy for Pandemic Influenza (the Implementation Plan) was issued by the President on May 3, 2006. The Implementation Plan translates the Strategy into more than 300 actions for Federal departments and agencies and sets expectations for State and local governments and other non-Federal entities. FDA's Center for Biologics Evaluation and Research is the lead for the vaccine action items under section 6.1.13.9 parts
(1)and
(3)of chapter 6 of the Implementation Plan. This section, in part, states that HHS, in coordination with the Department of Defense, the Veteran's Administration, and in collaboration with State, territorial, tribal, and local partners, shall develop and refine mechanisms to:
(1)Track adverse events following vaccine and antiviral administration; and
(2)define protocols for conducting vaccine- and antiviral-effectiveness studies during a pandemic, within 18 months. FDA conveyed in our May 31, 2007, Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (72 FR 30599), that all sponsors who seek licensure of a pandemic influenza vaccine should expect FDA to seek their involvement in working with FDA and other governmental agencies on plans to collect additional safety and effectiveness data, such as through epidemiological studies, when the vaccine is used (see *http://www.fda.gov/cber/gdlns/panfluvac.htm* ). FDA and the Centers for Disease Control and Prevention are engaged in discussions about adverse events surveillance during early use of influenza vaccines for pre-pandemic and pandemic situations. Relevant to the actions outlined in the preceding paragraph, we are inviting vaccine manufacturers who are pursuing the development of pre-pandemic and pandemic influenza vaccines, as well as other interested persons, to provide comments and information concerning mechanisms to track adverse events following vaccination, and the development of protocols to study effectiveness of influenza vaccines during a pandemic. Specifically, we are requesting information on the design of potential studies to assess the effectiveness of influenza vaccine in a pandemic situation, including comments on the potential usefulness of randomized trials, case control studies, or additional study designs, as well as, potential endpoints. In addition, we are seeking comments on organizations and entities, such as managed care organizations, or other public or private entities that may be able to partner with manufacturers and sponsors to assess safety and effectiveness. We are requesting comments and information to help us understand the complex issues encountered in trying to obtain these data during a pandemic. Your comments and information might assist us in the development of additional guidance documents for the conduct of postmarketing safety surveillance and effectiveness studies for pandemic influenza vaccines. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and information regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in the brackets in the heading of this document. A copy of this document and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the National Strategy for Pandemic Influenza, issued November 2005, and the Implementation Plan for the National Strategy, issued May 3, 2006, at ( *http://www.pandemicflu.gov/plan/federal/index.html* ). Dated: September 27, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-19577 Filed 10-3-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration
(HRSA)publishes periodic summaries of proposed projects being developed for submission to Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on
(301)443-1129. Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: HRSA AIDS Drug Assistance Program Quarterly Report—(OMB No. 0915-0294): Revision HRSA's AIDS Drug Assistance Program
(ADAP)is funded through Part B of Title XXVI of the Public Health Service Act, the Ryan White HIV/AIDS Program, which provides grants to States and Territories. The ADAP provides medications for the treatment of HIV disease. Program funds may also be used to purchase health insurance for eligible clients or for services that enhance access, adherence, and monitoring of drug treatments. Each of the 50 States, the District of Columbia, Puerto Rico, and several Territories receive ADAP grants. As part of the funding requirements, ADAP grantees submit quarterly reports that include information on patients served, pharmaceuticals prescribed, pricing, and other sources of support to provide AIDS medication treatment, eligibility requirements, cost data, and coordination with Medicaid. Each quarterly report requests updates from programs on number of patients served, type of pharmaceuticals prescribed, and prices paid to provide medication. The first quarterly report of each ADAP fiscal year (due in July of each year) also requests information that only changes annually (e.g., State funding, drug formulary, eligibility criteria for enrollment, and cost-saving strategies including coordinating with Medicaid). The quarterly report represents the best method for HRSA to determine how ADAP grants are being expended and to provide answers to requests from Congress and other organizations. The estimated annual burden is as follows: Form Number of respondents Responses per respondent Total responses Hours per response Total burden hours 1st Quarterly Report 57 1 57 3 171 2nd, 3rd, & 4th Quarterly Reports 57 3 171 1.5 256.5 Total 57 228 427.5 Send comments to Susan G. Queen, PhD, HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: September 28, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-19599 Filed 10-3-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Hepatitis C Virus Cell Culture System *Description of Technology:* Hepatitis C virus
(HCV)infection causes chronic liver disease and is a major global health problem with an estimated 170 million people affected worldwide and 3-4 million new cases every year. Therapeutic advances will be greatly aided by the ability of researchers to successfully replicate and characterize the virus in vitro. The study of HCV replication has, however, been hindered by the lack of an efficient virus culture system. One approach, using cell culture adaptive mutations in the viral RNA has been found to significantly enhance HCV virus production, but it has been difficult to define which stage of the viral lifecycle is affected by a given adaptive mutation. NIH researchers have now developed a single-cycle virus production system that allows the stage of the viral lifecycle affected by a specific adaptive mutation to be determined. They have isolated a unique subclone of Huh 7 Hepatoma cells, S29, that permits HCV replication and infectious virion release, but is resistant to infection by HCV. This permits the use of single cycle growth studies, and removes the confounding effects of virus re-infection allowing progress to be made on structure/function studies, or on studies of the effects of drugs on replication and virus assembly. *Applications:* HCV drug discovery; HCV single-cycle virus studies; HCV structure/function studies. *Market:* HCV research. *Inventors:* Suzanne U. Emerson, Robert H. Purcell, Rodney Russell (NIAID). *Patent Status:* HHS Reference No. E-324-2007/0—Research Tool. Patent protection is not being sought for this technology. *Licensing Status:* Available for licensing. *Licensing Contact:* Chekesha S. Clingman, Ph.D.; 301/435-5018; *clingmac@mail.nih.gov* . Use of CpG Oligodeoxynucleotides To Induce Epithelial Cell Growth *Description of Invention:* Wound repair is the result of complex interactions and biologic processes. Three phases have been described in normal wound healing: acute inflammatory phase, extracellular matrix and collagen synthesis, and remodeling. The process involves the interaction of keratinocytes, fibroblasts and inflammatory cells at the wound site. The sequence of the healing process is initiated during an acute inflammatory phase with the deposition of provisional tissue. This is followed by re-epithelialization, collagen synthesis and deposition, fibroblast proliferation, and neovascularization, all of which ultimately define the remodeling phase. These events are influenced by growth factors and cytokines secreted by inflammatory cells or by the cells localized at the edges of the wound. Tissue regeneration is believed to be controlled by specific peptide factors which regulate the migration and proliferation of cells involved in the repair process. Thus, it has been proposed that growth factors will be useful therapeutics in the treatment of wounds, burns and other skin disorders. However, there still remains a need for additional methods to accelerate wound healing and tissue repair. This application claims methods of increasing epithelial cell growth. The methods include administering a therapeutically effective amount of a CpG oligodeoxynucleotide
(ODN)to induce epithelial cell division. Also claimed are methods of inducing wound healing. The method includes treating the wound with a CpG oligonucleotide, thereby inducing wound healing. The wound can be any type of wound, including trauma or surgical wounds. The CpG ODN can be applied systemically or locally. *Application:* Induction of wound healing through use of CpG oligodeoxynucleotides. *Developmental Status:* CpG oligonucleotides have been synthesized and preclinical studies have been performed. *Inventors:* Dennis Klinman and Takahashi Sato (NCI). *Patent Status:* U.S. Provisional Application filed 06 Sep 2007 (HHS Reference No. E-242-2007/0-US-01). *Licensing Status:* Available for exclusive or nonexclusive licensing. *Licensing Contact:* Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov* . *Collaborative Research Opportunity:* The Laboratory of Experimental Immunology of the National Cancer Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize methods of increasing epithelial cell growth. Please contact John D. Hewes, Ph.D. at 301-435-3121 or *hewesj@mail.nih.gov* for more information. Flexible, Polyvalent Antiviral Dendritic Conjugates for the Treatment of HIV/AIDS *Description of Technology:* This technology describes the design and synthesis of flexible, polyvalent, antiviral conjugates of less than 200 kDa for the treatment of HIV/AIDS. These conjugates are mimetic of D1D2-Igαtp, a high-molecular-weight (1 MDa) CD4-immunoglobulin fusion construct with extreme HIV neutralizing potency. Cryo electron microscopy suggests that the extreme potency of D1D2-Igαtp is due to polyvalent presentation of a gp120-binding ligand on a flexible scaffold. The current prototype for the technology is a conjugate comprising soluble, two-domain human CD4 covalently linked to a flexible poly(ethylene glycol)-PAMAM dendrimer scaffold. The construct is designed to retain a high degree of flexibility and polyvalence, and, at less than 200 kDa, is similar in size to successful antibody therapeutics currently on the market. Because it retains the key determinants of potency and the human CD4 moieties of D1D2-Igαtp, this conjugate is expected to have the following unique set of HIV antiviral properties:
(1)IC 90 infectivity neutralization values in the nanomolar range against HIV primary isolates;
(2)lack of susceptibility to viable escape mutations, because the ligand is CD4, and because CD4-independence evolves concomitantly with constitutive exposure of neutralization-sensitive, highly conserved coreceptor binding site epitopes;
(3)indefinite control of HIV viral replication, without the need for combination therapy, arising from properties
(1)and (2);
(4)improved HIV viral replication control when used in combination with other Highly Active Antiretroviral Therapy (HAART);
(5)improved prevention of seroconversion when used in combination with other HAART shortly following known exposure to HIV. *Applications:* Novel therapeutics for the treatment and prevention of HIV infection. *Development Status:* Synthesis and characterization in progress. *Inventors:* Sriram Subramaniam and Adam Bennett (NCI). *Publication:* AE Bennett *et al.* Cryo electron tomographic analysis of an HIV neutralizing protein and its complex with native viral gp 120. J Biol Chem., in press; published online ahead of print June 28, 2007. *Patent Status:* U.S. Provisional Application No. 60/932,464 filed 31 May 2007 (HHS Reference No. E-213-2007/0-US-01). *Licensing Status:* Available for licensing. *Licensing Contact:* Sally Hu, Ph.D.; 301/435-5606; *HuS@mail.nih.gov.* *Collaborative Research Opportunity:* The Laboratory of Cell Biology of the National Cancer Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Flexible, Polyvalent Antiviral Dendritic Conjugates for the Treatment of HIV/AIDS. Please contact John D. Hewes, Ph.D. at 301-435-3121 or *hewesj@mail.nih.gov* for more information. Monoclonal Antibodies to Fusion-Active Conformations of GP41 *Description of Technology:* This technology describes three novel monoclonal antibodies, 2F12, 9C5 and 11B8, which were derived against an HIV gp41 heptad-repeat entry inhibitor that mimics a structure of the HIV envelope protein fusion intermediate. These antibodies recognize the fusion-intermediate and six-helix conformations of gp41 and are useful tools for high-throughput screening assays
(HTS)to identify novel HIV-1 inhibitors. Since the drugs identified in the assays using these monoclonal are expected to inhibit HIV infection in a different manner than current antiretroviral drugs, these antibodies may serve as valuable tools for screening for new drugs that may have activity against HIV strains that are resistant to currently available antiretroviral drugs. *Applications:* Research tool. *Development Status:* *In vitro* data available . *Inventors:* Carol D. Weiss and Russell A. Vassell (CBER/FDA). *Related Publication:* S Jiang et al. A screening assay for antiviral compounds targeted to the HIV-1 gp41 core structure using a conformation-specific monoclonal antibody. J Virol Methods. 1999 Jun;80(1):85-96. *Patent Status:* HHS Reference No. E-124-2007/0—Research Tool. Patent protection not being pursued for this technology. *Licensing Status:* Available for non-exclusive licensing as biological material. *Licensing Contact:* Sally Hu, Ph.D.; 301/435-5606; *HuS@mail.nih.gov.* Dated: September 27, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-19649 Filed 10-3-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of Portfolio Analysis and Strategic Initiatives, Office of the Director, National Institutes of Health; Notice of Meeting Notice is hereby given of a planning meeting for the proposed Council of Councils, an external advisory panel to the NIH IC Directors and the Office of Portfolio Analysis and Strategic Initiatives (OPASI). The meeting will be open to the public, with attendance limited to space available. individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. *Name of Committee:* Council of Councils Planning Group. *Date:* November 8, 2007. *Time:* 8:30 a.m. to 5:00 p.m. *Agenda:* Among the topics proposed for discussion are: Role of the Council and timeline. *Place:* National Institutes of Health, Building 31, Conference Room 6, 9000 Rockville Pike, Bethesda, MD 20892. *Contact Person:* Robert D. Hammond, PhD, Consultant To OPASI, 301-977-9307, *bhammond@thehillgroup.com* . Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number, and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit. Information is also available on the Institute's/Center's Web page: *http://opasi.nih.gov/council/* where an agenda and any additional information for the meeting will be posted when available. Dated: September 18, 2007. Alan M. Krensky, Director, Office of Portfolio Analysis and Strategic Initiatives (OPASI). [FR Doc. 07-4932 Filed 10-3-07; 8:45 am]
Connectionstraces to 7
8 references not yet in our index
  • Pub. L. 99-660
  • Pub. L. 103-183
  • 21 CFR 172
  • 44 USC 3501-3520
  • 21 CFR 807
  • 21 CFR 820
  • 21 CFR 801
  • Pub. L. 104-13
Citation graph
cites case law
Notices
Notice of Availability and Public Hearing
U.S.C.§ 300aa–26
U.S.C.§ 348
C.F.R.§ 25.32
C.F.R.§ 880.2800
C.F.R.§ 10.115
C.F.R.§ 870.9
U.S.C.§ 207
Pub. L.Pub. L. 99-660
Pub. L.Pub. L. 103-183
Cite21 CFR 172
Cite44 USC 3501-3520
Cite21 CFR 807
Cites 15 · showing 12Cited by 0 across 0 sources
★   the supreme law of the land   ★
Don't Tread on Me
E Pluribus Unum — out of many, one

"If you don't know your rights, you don't have any."

Marginalia · a citizen's law index
A research desk, not legal advice. Always read the cited source before relying on a summary.
Questions or an issue? support@self-law.org
disclaimerMarginalia is a research index, not a law firm. Nothing on this site is legal, tax, or financial advice and no attorney–client relationship is formed by using it. Statutes, regulations, and case law change; summaries, search results, AI output, and member posts may be incomplete, out of date, or wrong. Any interpretation drawn from material on this site should be validated by a licensed attorney in your jurisdiction before you act on it.